FDA 510(k)

Elecsys FT4 III

K号: K181233 · 2018-09-18

决定日期2018-09-18

产品代码CEC

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Elecsys FT4 III is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K181233. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys FT4 III?

Elecsys FT4 III is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Roche Diagnostics. The 510(k) number is K181233.

When did Elecsys FT4 III receive FDA 510(k) clearance?

Elecsys FT4 III received FDA 510(k) clearance on 2018-09-18, under 510(k) number K181233.

Who is the listed applicant for Elecsys FT4 III?

FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Elecsys FT4 III?

The FDA product code for Elecsys FT4 III is CEC.

列明Roche Diagnostics为申报人的其他记录

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